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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name condom
510(k) Number K051842
Device Name GREEN LOVE MALE CONTRACEPTIVE (CONDOM)
Applicant
CUPID CONDOM, LTD.
A-68, MIDC SINNAR, (MALEGAON)
nashik, maharashtra,  IN 422 113
Applicant Contact k.k. goyal
Correspondent
CUPID CONDOM, LTD.
A-68, MIDC SINNAR, (MALEGAON)
nashik, maharashtra,  IN 422 113
Correspondent Contact k.k. goyal
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/07/2005
Decision Date 04/14/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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